BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCIRA CHECK-IT COVID-19 TEST

    MDR report key: 19003934 · Received March 29, 2024

    Report

    Report Number
    3016521623-2024-00513
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 20, 2024
    Report Date
    March 29, 2024
    Manufacturer
    PFIZER, INC
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS BASED ON THE AVAILABLE INFORMATION CAPTURED IN THE COMPLAINT DETAILS. THE ISSUE OF "FALSE NEGATIVE" WAS REPORTED. PRODUCT IS USED FOR DIAGNOSTIC PURPOSES. NO HARM(S) WERE REPORTED. REFER TO (B)(4)_INVESTIGATION_28MAR2024.PDF FOR THE COMPLETE INVESTIGATION. WITHOUT RECEIPT/EVALUATION OF A RETURNED SAMPLE, NO FURTHER EVALUATION IS REQUIRED. CAPA-000020 IS OPEN TO ADDRESS THE PROCESS FOR EVALUATING RETURN SAMPLES. BASED ON THE INFORMATION ABOVE, NO FURTHER INVESTIGATION IS REQUIRED. MONITORING OF "FALSE NEGATIVE" WILL CONTINUE AND THERE ARE NO ADDITIONAL RECOMMENDED ACTIONS AT THIS POINT. A MOST PROBABLE ROOT CAUSE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: - NO AMPLIFICATION/REDUCED AMPLIFICATION EFFICIENCY (DESIGN DEFECT) - ASSAY CONTAMINATION/DEGRADATION (PROCESS FAILURE) - IMPROPER STORAGE/HANDLING (USE ERROR).

    Description of Event or Problem · 0

    "CUSTOMER CONTACTED US ON (B)(6) 2024 TO REPORT 4 FALSE NEGATIVE FLU B TEST RESULTS. TESTS WERE PERFORMED ON (B)(6) 2024. EVIDENCE PROVIDED. FALSE NEGATIVE FOR FLU B BEFORE STARTING, WERE THE INSTRUCTIONS READ? Y/N YES MAY I HAVE YOUR LOT AND TEST KIT #? LOT #: K10A011307233M1 / K10A011307233M7 / K10A011307233M1 / K10A011307233M3 TEST KIT #: 3A9W9B6U / 3A9Y0F3Q / 3A9W9B6L / 3A9W2C2D LOCATION OF TESTING? INDOOR/OUTDOOR. INDOOR WAS THE TEST COMPLETED ON A FLAT SURFACE? Y/N YES WAS THE SWAB ROTATED 5 TIMES IN EACH NOSTRIL? Y/N YES ) WAS THE VIAL LIQUID PURPLE IN COLOR? Y/N YES WAS THE TEST MOVED WHILE IT WAS RUNNING? Y/N NO HOW SOON AFTER THE INITIAL NEGATIVE TEST WAS A RETEST(S) COMPLETED? 30MIN WHAT TEST DID YOU USE TO CONFIRM THE FALSE NEGATIVE? LUCIRA COVID & FLU HOW MANY TOTAL TESTS WERE RUN BEFORE GETTING THIS FALSE NEGATIVE? - DID THE PERSON TESTED, CONTACT A HEALTHCARE PROVIDER? Y/N YES IF YES, HOW IS THE PERSON TESTED DOING? IS THE PERSON TESTED UNDERGOING ANY TREATMENT? NO IS YOUR KIT COVID/ FLU OR COVID 19? COVID FLU PLEASE PROVIDE THE STATUS OF EACH LED STATUS? (ONLY FOR COVID/ FLU KITS) COVID LED STATUS: NEGATIVE::OFF FLU A LED STATUS: NEGATIVE::OFF FLU B LED STATUS: NEGATIVE::OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242988 LUCIRA CHECK-IT COVID-19 TEST COVID-19-TEST KIT QJR PFIZER, INC K10A011307233M1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other